Cleaning validation engineer

Description:

The Validation Engineer, as part of the project Validation team, will be responsible for the timely validation of cleaning processes. This includes a large variety of CIP processes on the typical biopharmaceutical processing systems (bioreactors, centrifuges, buffer/media vessels, filtrations skid etc.) as well as parts washers cleaning. Hands-on activity envisaged in relation to this (e.g. swabbing activities)

The role will involve working as part of the larger QA Validation organization and engaging with various groups and departments including manufacturing and quality.

General Scope of Responsibilities

• Documentation cleaning validation protocol/reports
• Scheduling of cleaning validation within production schedule
• Support and coordinate physical testing
• Provide expertise and participate in troubleshooting within team (Manufacturing, QA)
• Cross-functional communication

Requirements

Essential

• Knowledge of pharmaceutical plant qualification, preferably in a biotechnology process environment.
• Knowledge of cleaning validation, including the CIP/COP methodology.
• Good understanding of the regulatory GMP requirements in EU and US for biotech operations (such as Eudralex, ICH, 21CFR) including area classifications (ISO 14644 and EU Annex 1).
• Literate in computer operating systems and applications such as Windows, MS Word and Excel.

Preferred

• Qualified with relevant technology degree (or equivalent).
• Emerson Delta V automation system competency.
• Knowledge of EU and US Pharmacopoeia.
• Operating experience in the pharmaceutical industry, ideally in a biotechnology process environment.

Personal / Team Skills:

Essential

• Able to communicate and write documentation in English and Dutch.
• Results oriented with good organizational skills.
• Able to working in an very flexible schedule.
• Strong quality and safety focus
• Excellent communication skills
• Previous experience working in a team based environment